Â鶹´«Ã½Ó³»­

Â鶹´«Ã½Ó³»­

Explore the latest content from across our publications
Join The Â鶹´«Ã½Ó³»­

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Rationale and Design of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson’s Disease on Stable Dopaminergic Treatment
Movement Disorders
P10 - Poster Session 10 (5:30 PM-6:30 PM)
3-006
Assessment of motor function in the practically defined off-medication state (≥12 hours off levodopa) in subjects with Parkinson’s disease (PD) following treatment for 12 weeks with placebo or AKST4290, a highly specific and potent small molecule antagonist of CCR3.

Development of novel therapeutic strategies in PD remains a major unmet need. Increased eotaxin is associated with age-related diseases, such as PD, where it is upregulated in the substantia nigra and may contribute to the worsening of neuroinflammation leading to progressive neuronal loss. AKST4290 demonstrated beneficial effects on motor function, microgliosis, and immune cell infiltration in mouse models of PD. The anti-neuroinflammatory effects were observed as early as 3 days after start of treatment, and motor improvement was observed within 3-5 weeks.
Approximately 120 men and women (50-80 years) with PD on stable L-DOPA treatment will be randomly allocated (1:1) to AKST4290 or placebo for 12 weeks. The study includes seven in-clinic visits:  screening visit, baseline visit, treatment visits (x4), and a follow-up visit. Motor, functional, and other efficacy assessments, as well as safety and tolerability assessments, will be performed at various time points.  
The primary endpoint is the change from baseline in motor function during the off-medication state at 12 weeks as measured by the MDS-UPDRS Part 3. Secondary endpoints include assessment of safety/tolerability and changes in clinical function, motor function, and activities of daily living during the on-medication state using validated scales. Exploratory endpoints include pharmacokinetic assessments, pharmacogenomics/biomarkers, motor assessments via a wearable device, and, in consenting subjects, changes in gut microbiome markers.
Robust preclinical evidence in rodent models of PD provides the foundation for development of this novel therapeutic approach in humans.  In this Phase 2 study, the efficacy and safety of 12 weeks of AKST4290 in subjects with PD will be assessed. 
Authors/Disclosures
Jessica Powell
PRESENTER 		No disclosure on file
Esther Rawner, MD Dr. Rawner has received personal compensation for serving as an employee of Alkahest Inc. Dr. Rawner has received stock or an ownership interest from Alkahest Inc.
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file